Forty-four new guidance documents on medical devices and diagnostics issued by regulatory authorities from around the world were added to Medtech Insight's Guidance Tracker in the last two months (from Oct. 12 to Nov. 30).
The US FDA issued 12 guidelines since the last update, including a final document explaining when to submit a 510(k) for a software change to an existing device. While the guideline is helpful, an industry expert believes it does not do enough to address the bigger issue of allowing FDA more discretion to let software medical device-makers update their products quickly without burdensome agency oversight. (Also see "Despite 510(k) Software Guidance, US FDA's Hands May Still Be Tied" - Medtech Insight, 17 Nov, 2017.)
The updated list also includes a draft guideline from the Saudi Food and Drug Authority outlining the procedure that local manufacturers and authorized representatives should follow to address field safety notices (FSNs) issued in relation to their devices.
The updated list of new guidance documents is below. The full Medtech Guidance Tracker is online.
Medtech Guidance Tracker: October-November 2017
WHO: World Health Organization
HC: Health Canada
EMA: European Medicines Agency
NBOG: Notified Body Operations Group
HPRA: Health Products Regulatory Authority
MDA: Medical Device Authority
FDA Philippines: Food and Drug Administration Philippines
Saudi FDA: Saudi Food & Drug Authority
HSA: Health Sciences Authority
MCC: Medicines Control Council
Swissmedic: Swiss Agency for Therapeutic Products
MHRA: Medicines and Healthcare products Regulatory Agency
FDA: Food and Drug Administration